Not Yet RecruitingPhase 2

Frontline Risk-Adapted Optimization of Novel Targeted Immunotherapy Evaluation in High-Risk MCL

52 participantsStarted 2026-09

Plain-language summary

FRONTIER is a prospective, single arm, open label, multi-center, Phase II study of MB-CART2019.1 (Zamtocabtagene Autoleucel) therapy as frontline consolidation for high-risk Mantle Cell Lymphoma (MCL) participants

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject should have a tumor biopsy sample (at least 5 unstained slides of tissue or tissue block) available prior to MB-CART2019.1 infusion, preferably collected pre-induction.
✓. If archival tissue is not available, the patient may be enrolled after discussion with the protocol chair and/or protocol officer
✓. High risk MIPI-c (as calculated by https://www.european-mcl.net/home/scores-mipi-mipi-c-19.html)
✓. Simplified MIPI high-risk ≥6.2
✓. TP53 mutation OR ≥50% TP53 expression by IHC
✓. Complex Karyotype \[e.g. 3 or more cytogenetic abnormalities, excluding the presence or absence of t(11:14)\]
✓. Ki67≥ 50%
✓. Blastoid or pleomorphic histology with Ki-67 ≥30%

Exclusion criteria

✕. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
✕. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study
✕. Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years -or- low-grade untreated prostate cancer under observation
✕. A primary malignancy which has been completely resected / treated with curative intent and in complete remission of ≥ 2 years
✕. Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety and efficacy assessment are eligible for this trial after discussion with protocol chair or protocol officer

What they're measuring

Progression-free survival (PFS)

Timeframe: 1 year post-infusion

Trial details

NCT IDNCT07569965

SponsorMiltenyi Biomedicine GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-09

Contact for this trial

Sadie Swift

617-218-0044 clinicaltrials@miltenyi.com

View on ClinicalTrials.gov More Mantle Cell Lymphoma (MCL) trials